NCT01806194

Brief Summary

The EMPOWER diabetes program is a year-long, community-based program designed to enhance diabetes management in rural African American women with uncontrolled diabetes. The treatment is delivered by community peers and follows a relative Small Changes approach.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 7, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

January 21, 2016

Status Verified

January 1, 2016

Enrollment Period

2.5 years

First QC Date

December 5, 2012

Last Update Submit

January 19, 2016

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Change in Hemoglobin A1c

    Glycosylated hemoglobin

    6 months

  • Change in Hemoglobin A1c

    Glycosylated hemoglobin

    12 Months

Secondary Outcomes (2)

  • Change in Weight

    6 Months

  • Change in Weight

    12 Months

Other Outcomes (2)

  • Blood pressure

    6 months

  • Blood Pressure

    12 Months

Study Arms (2)

Educational control arm

ACTIVE COMPARATOR

Control group receives 16 mailings of diabetes educational materials but no regular contact with community health workers

Behavioral: Educational Control Arm

Lifestyle counseling

EXPERIMENTAL

Small changes behavioral counseling and social support, delivered in 16 sessions by community health workers.

Behavioral: Lifestyle Counseling

Interventions

Lifestyle CounselingBEHAVIORAL

Small changes behavioral counseling and social support, delivered in 16 sessions by community health workers

Lifestyle counseling
Educational Control ArmBEHAVIORAL

16 mailings of diabetes educational materials but no regular contact with community health workers

Educational control arm

Eligibility Criteria

Age19 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • African American female,
  • age 19 - 75yr.,
  • with Type 2 diabetes mellitus and
  • living in or near Bertie, Edgecombe, and Pitt counties in eastern NC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Related Publications (3)

  • Cummings DM, Lutes LD, Littlewood K, Dinatale E, Hambidge B, Schulman K. EMPOWER: a randomized trial using community health workers to deliver a lifestyle intervention program in African American women with Type 2 diabetes: design, rationale, and baseline characteristics. Contemp Clin Trials. 2013 Sep;36(1):147-53. doi: 10.1016/j.cct.2013.06.006. Epub 2013 Jun 19.

    PMID: 23792133BACKGROUND

  • Cummings DM, Lutes L, Littlewood K, DiNatale E, Hambidge B, Schulman K, Morisky DE. Regimen-Related Distress, Medication Adherence, and Glycemic Control in Rural African American Women With Type 2 Diabetes Mellitus. Ann Pharmacother. 2014 Aug;48(8):970-977. doi: 10.1177/1060028014536532. Epub 2014 Jun 5.

    PMID: 24904183BACKGROUND

  • Lutes LD, Cummings DM, Littlewood K, Dinatale E, Hambidge B. A Community Health Worker-Delivered Intervention in African American Women with Type 2 Diabetes: A 12-Month Randomized Trial. Obesity (Silver Spring). 2017 Aug;25(8):1329-1335. doi: 10.1002/oby.21883. Epub 2017 Jun 29.

    PMID: 28660719DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Doyle M. Cummings, Pharm.D.

    East Carolina University

    PRINCIPAL INVESTIGATOR

  • Lesley Lutes, Ph.D.

    East Carolina University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Family Medicine

Study Record Dates

First Submitted

December 5, 2012

First Posted

March 7, 2013

Study Start

January 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

January 21, 2016

Record last verified: 2016-01

Locations

US(1)